Label: SEVERE COLD PLUS FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit
- NDC Code(s): 69842-546-12
- Packager: CVS Pharmacy,Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- ▪
- temporarily relieves these symptoms due to a cold or flu:
- ▪
- minor aches and pains
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- headache
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- sore throat
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- cough
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- nasal congestion
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- sinus congestion and pressure
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- ▪
- temporarily reduces fever
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- ▪
- more than 6 packets in 24 hours, which is the maximum daily amount for this product
- ▪
- with other drugs containing acetaminophen
- ▪
- 3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- ▪
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- ▪
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- ▪
- if you have ever had an allergic reaction to this product or any of its ingredients
- ▪
- in children under 12 years of age
Ask a doctor before use if you have
- ▪
- liver disease
- ▪
- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- difficulty in urination due to enlargement of the prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
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- cough with excessive phlegm (mucus)
Stop use and ask a doctor if
- ▪
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- ▪
- fever gets worse or lasts more than 3 days
- ▪
- redness or swelling is present
- ▪
- new symptoms occur
- ▪
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- ▪
- nervousness, dizziness, or sleeplessness occurs
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Directions
- ▪
- do not take more than the recommended dose
- ▪
- take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
- ▪
- adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- ▪
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- ▪
- more than 5 packets in 24 hours, which is the maximum daily amount for this product
- ▪
- with other drugs containing acetaminophen
- ▪
- 3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.
Do not use
- ▪
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- ▪
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- ▪
- if you have ever had an allergic reaction to this product or any of its ingredients
- ▪
- in children under 12 years of age
Ask a doctor before use if you have
- ▪
- liver disease
- ▪
- heart disease
- ▪
- high blood pressure
- ▪
- thyroid disease
- ▪
- diabetes
- ▪
- glaucoma
- ▪
- cough with excessive phlegm (mucus)
- ▪
- a breathing problem such as emphysema or chronic bronchitis
- ▪
- difficulty in urination due to enlargement of the prostate gland
- ▪
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
- ▪
- taking the blood thinning drug warfarin
- ▪
- taking sedatives or tranquilizers
When using this product
- ▪
- do not exceed recommended dosage
- ▪
- may cause marked drowsiness
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- avoid alcoholic drinks
- ▪
- alcohol, sedatives, and tranquilizers may increase drowsiness
- ▪
- be careful when driving a motor vehicle or operating machinery
- ▪
- excitability may occur, especially in children
Stop use and ask a doctor if
- ▪
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- ▪
- fever gets worse or lasts more than 3 days
- ▪
- redness or swelling is present
- ▪
- new symptoms occur
- ▪
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- ▪
- nervousness, dizziness, or sleeplessness occurs
-
Directions
- ▪
- do not take more than the recommended dose
- ▪
- take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
- ▪
- adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- ▪
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL-
Compare to Alka-Seltzer PLUS® Severe Cold +Flu Day and Night Active Ingredients*
DAYTIME
SEVERE COLD & FLU
Acetaminophen / Pain reliever-fever reducer
Dextromethorphan HBr / Cough suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestantRelieves:
• Nasal Congestion • Headache
• Sore Throat • Body Ache • Cough
• Mucus • Chest Congestion • FeverHoney Lemon Flavor
Naturally and Artificially Flavored
NIGHTTIME
Severe Cold & Flu
Acetaminophen / Pain reliever-fever reducer
Dextromethorphan HBr / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestantRelieves:
• Nasal Congestion • Headache
• Sore Throat • Body Ache
• Cough • Runny Nose • FeverHoney Lemon Flavor
Naturally and Artificially Flavored
TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN
DO NOT TAKE THESE PRODUCTS AT THE SAME TIME
6 DAY PACKETS + 6 NIGHT PACKETS
12 TOTALDistributed by: CVS Pharmacy, Inc.
One CVS Drive Woonsocket, RI 02895
©2017 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Money Back Guarantee
*These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night.
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INGREDIENTS AND APPEARANCE
SEVERE COLD PLUS FLU DAYTIME NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-546 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-546-12 1 in 1 CARTON; Type 0: Not a Combination Product 07/14/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTON 6 Part 2 1 CARTON 6 Part 1 of 2 SEVERE COLD PLUS FLU DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/14/2017 Part 2 of 2 SEVERE COLD PLUS FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/14/2017 Labeler - CVS Pharmacy,Inc. (062312574)